UM2HD111076

Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional) - Abstract – Overall

Adolescents and young adults (AYA) ages 13-24 accounted for 21% of new HIV diagnoses in the United States in 2019. New infections in AYA disproportionately affect Black, Latino, multiracial, and American Indian/Alaska Native men who have sex with men. Geographic areas of the United States are also disproportionately affected by new infections: Northeast > South > West followed by the Midwest.

The specific aim of the applicant is to serve as the Operations and Collaborations Center (OCC) of the Adolescent Trials Network (ATN). Westat is in an ideal position to expertly perform the ATN OCC scope of work (SOW) as outlined in RFA-HD-23-021 due to our prior and current successful experience supporting HIV pediatric and adolescent research programs.

The newly designed ATN network will be made up of a Scientific Leadership Center (SLC) and OCC. As the OCC, Westat will work collaboratively with the ATN SLC and provide operational and logistical infrastructure to support the ATN Executive Committee (EC). This is critical to the EC's success in achieving its scientific leadership agenda and in its collaborations with the ATN External Scientific Panel (ESP), National Institutes of Health (NIH) program staff, and external research networks and investigators.

The overall aims of the ATN OCC are to:

(1) Provide administrative management and coordinate network external collaborations;

(2) Provide operational support for cross-network protocols, collaborations, and other projects (e.g., conduct trainings, develop manuals of operation, network public support relations, provide network website maintenance, support communications and conference calls, convening committees and meetings);

(3) Train network participants on a breadth of research-related topics;

(4) Manage resources and execute performance-based subcontracts with site consortia, vendors, and collaborators;

(5) Provide regulatory infrastructure for cross-network protocols, collaborations, and emerging projects (e.g., site performance monitoring, quality assurance procedures, and protocol registration);

(6) Provide mechanisms and metrics to monitor subject screening, recruitment, retention, and dropout, and procedures for adjustment if enrollment targets are not being met;

(7) Provide detailed systems for tracking study progress and performance of site consortia and reporting to the EC (e.g., support of a study progress and performance monitoring committee). Routine tracking and reporting will include defined metrics, milestones, timelines, and quality-control measures to ensure studies stay on track and within budget.

Relevance: Westat will provide the appropriate technical, organizational, administrative expertise, and resources to efficiently design, implement, and simultaneously manage a broad portfolio of therapeutic, behavioral, and community studies. Study findings will be used to develop interventions for reducing HIV transmission and acquisition among AYA, safe and effective forms of long-acting HIV pre-exposure prophylaxis (PrEP), and long-acting antiretroviral therapies (ARTs) for improving adherence and long-term health outcomes of AYA living with HIV (LHIV).

Westat

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Maryland United States

State-Wide

Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) (PA-20-272)

Termination This cooperative agreement was reported as terminated by the Department of Government Efficiency (DOGE) in July 2025. See All
Amendment Since initial award the total obligations have increased 233% from $7,389,531 to $24,596,695.